Reported Reactions

Drugs

Product name as reported

Blopress: adverse event reports filed with FDA

1,027 reports list it as a suspect or interacting product, 2004–2021.

1,027
reports as suspect product
0% of all reports · about 46 a year
0
reports, 12 months to June 2026
0 in the 12 months before
97.1%
marked serious by the reporter
57.4% across all reports
10.3%
record death among outcomes, as reported
106 reports · not verified by FDA

Between January 2004 and June 2021, 1,027 adverse event reports received by FDA list the product name "Blopress" as reporters wrote it as a suspect or interacting product. Reports that mention it only as a concomitant medication (4,272) are left out of every figure here.

In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 46 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded interstitial lung disease (6.8%), rhabdomyolysis (6.6%) and drug interaction (4.7%). A report can list several reactions, so shares add to more than 100%; 246 different terms appear across these reports. Interstitial lung disease is recorded in 6.8% of these reports, against 0.2% of all reports in the database.

97.1% of the reports are marked serious by the reporter; 10.3% record death among the outcomes and 56.7% record hospitalisation, as reported. 49% of the reports came from physicians, and the largest patient age group is 75 and over (30.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

No report listing Blopress was received in the five years to June 2026; the latest was received in June 2021.

By year received

0531052004: 8720042005: 832006: 8320062007: 522008: 10520082009: 1042010: 6420102011: 382012: 3320122013: 652014: 8220142015: 682016: 5520162017: 552018: 2520182019: 182020: 720202021: 3

Reactions recorded in the reports

share of Blopress reports recording the termall reports in the database

  1. Interstitial lung diseasescarring or inflammation of lung tissue6.8%70
  2. Rhabdomyolysismuscle breakdown6.6%68
  3. Drug interactionan interaction between medicines4.7%48
  4. Hyperkalaemiahigh blood potassium4%41
  5. Renal impairmentreduced kidney function3.4%35
  6. Cardiac failureheart failure3.2%33
  7. Blood creatinine increasedraised creatinine, a kidney test2.6%27
  8. Blood pressure decreaseda low blood pressure reading2.6%27
  9. Hypotensionlow blood pressure2.5%26
  10. Hypoglycaemialow blood sugar2.4%25
  11. Dizzinesslight-headedness or unsteadiness2.3%24
  12. Decreased appetitereduced appetite2.1%22
  13. Pyrexiafever2.1%22
  14. Condition aggravatedthe condition being treated got worse2%21
  15. Malaisegeneral feeling of being unwell1.9%20
  16. Atrial fibrillationan irregular heart rhythm1.9%19
  17. Bradycardiaslow heart rate1.8%18
  18. Dehydrationdehydration1.8%18
  19. Alanine aminotransferase increasedraised liver enzyme (ALT)1.7%17
  20. Anaemialow red blood cells1.7%17
  21. Aspartate aminotransferase increasedraised liver enzyme (AST)1.6%16
  22. Diarrhoealoose or frequent stools1.5%15
  23. Blood pressure increaseda raised blood pressure reading1.4%14
  24. Loss of consciousnesspassing out1.4%14

Top 30 of 246 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Death10.3%106
Life-threatening11.3%116
Hospitalisation (initial or prolonged)56.7%582
Disability5.2%53
Congenital anomaly1.2%12
Other serious38.9%400
Not serious2.9%30

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 21%10
2 to 110.6%6
12 to 170.5%5
18 to 445%51
45 to 6417.4%179
65 to 7423.9%245
75 and over30.8%316
Age not given20.9%215

Patient sex

Female44.2%454
Male48.5%498
Not given7.3%75

Who reported

Physician49%503
Pharmacist12.2%125
Other health professional17.4%179
Lawyer0%0
Consumer or non-health professional7.7%79
Not given13.7%141

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 4.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Hypertension58256.7%
Cardiac failure chronic403.9%
Essential hypertension171.7%
Cardiac failure151.5%
Ill-defined disorder30.3%
Aortic valve incompetence20.2%

The indication field is filled in by the reporter and is often blank; shares are of all 1,027 reports.

In context

MeasureBlopressAll reports
Reports as suspect product1,02720,646,523
Share of that pool—0%
Reports, latest 12 months01,332,454
Marked serious97.1%57.4%
Death recorded among outcomes, per 1,000 reports10391
Hospitalisation recorded, per 1,000 reports567213
Consumer-filed share7.7%45.8%
Top term, share of reportsInterstitial lung disease 6.8%0.2%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Questions about Blopress reports

How many adverse event reports has FDA received for Blopress?

1,027 reports list Blopress as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 4,272 list it only as a concomitant medication.

What reactions are recorded in Blopress reports?

interstitial lung disease (6.8%), rhabdomyolysis (6.6%), drug interaction (4.7%), hyperkalaemia (4%) and renal impairment (3.4%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Blopress was responsible.

How serious are the reports?

97.1% are marked serious by the reporter. Among the outcomes recorded, 10.3% of reports include death and 56.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

physician (49%), other health professional (17.4%) and not given (13.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Blopress rising?

0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Blopress was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Blopress?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Blopress as a suspect or interacting product; reports listing it only as a concomitant medication (4,272) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.